Viral-mediated gene therapy and genetically modified therapeutics: A primer on biosafety handling for the health-system pharmacist
Abstract
PURPOSE: The guidance documents applicable to the manipulation of viral vectors in a health-system pharmacy are reviewed to provide recommendations for occupational safe drug handling. SUMMARY: Biosafety handling principles should be drawn from 2 guidance documents essential in the manipulation of biological material: Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. and the National Institute of Health's NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Incorporating the biosafety guidance of these 2 documents into the pharmaceutical standards of United States Pharmacopeia chapter 800, "Hazardous Drugs-Handling in Healthcare Settings," will assist in the establishment of viral gene therapy handling guidelines in a health-system pharmacy. CONCLUSION: Novel gene therapies and genetically modified therapeutic products will expose health-system pharmacists to classes of medications with unique biological handling requirements. Occupational safety data on the handling of these medications will be limited. The health-system pharmacy will need to rely on published biosafety recommendations to evaluate the infectious and genotoxic risks of these products while determining the necessary containment strategies to ensure safe work practice.
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Most Investigator Brochures and the product insert of ZOLGENSMA recommend 30-day universal or standard precautions.
“Most of the Investigator Brochures and also the product insert of ZOLGENSMA recommend 30-day universal or standard precautions.126,128”
From Viral Vector Systems for Gene Therapy: A Comprehensive Literature Review of Progress and Biosafety Challenges (2020) · cites this paper as [126]
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- Authors
- Blind, J. E., McLeod, E. N., & Campbell, K. J.
- Affiliations
- Nationwide Children's Hospital (US)
- Corresponding author
- Blind, Jill E
- ORCID
- Blind, Jill E
- Venue
- American Journal of Health-System Pharmacy
- Publisher
- Oxford University Press (OUP)
- Published
- 2019-05-17
- Volume
- 76
- Issue
- 11
- Pages
- 795-802
- ISSN
- 1079-2082 (ISSN-L)
- 1535-2900
- OpenAlex
- W2946183644
- Cited by
- 26
- References
- 11
- Citations by year
- 2026: 3 · 2025: 7 · 2024: 3 · 2023: 4 · 2022: 2 · 2021: 2 · 2020: 4 · 2019: 1
- FWCI
- 4.79
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- American Journal of Health-System Pharmacy (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Health Professions › Occupational Therapy › Safe Handling of Antineoplastic Drugs
- Physical Sciences › Chemical Engineering › Chemical Health and Safety › Chemical Safety and Risk Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Virus-based gene therapy research
- Keywords
- viral vectors, gene therapy, biosafety, occupational safety, health-system pharmacy, hazardous drugs, containment strategies, genotoxic risk, infectious disease risk
- MeSH terms
- Containment of Biohazards, DNA Damage, Genetic Engineering, Genetic Vectors, Humans, Pharmaceutical Services, Pharmacists, Genetic Therapy, Occupational Health, Occupational Exposure
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